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Related Experiment Videos

Excipient selection can significantly affect solid-state phase transformation in formulation during wet granulation.

Sari Airaksinen1, Milja Karjalainen, Niina Kivikero

  • 1Pharmaceutical Technology Division, Faculty of Pharmacy, FIN-00014 University of Helsinki, Helsinki, Finland. sari.airaksinen@helsinki.fi

AAPS Pharmscitech
|December 16, 2005
PubMed
Summary

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Excipient properties significantly impact drug stability. Amorphous excipients prevent nitrofurantoin hydrate formation in wet granulation, enhancing formulation stability.

Area of Science:

  • Pharmaceutical Sciences
  • Materials Science
  • Chemical Engineering

Background:

  • Phase transformations in drug formulations can compromise physicochemical, biopharmaceutical, and processing properties.
  • Understanding formulation design's influence on optimal dosage forms is crucial for product stability.

Purpose of the Study:

  • To investigate how excipients with varying water sorption behaviors affect the hydrate formation of nitrofurantoin in wet granulation.
  • To determine the role of excipient characteristics in controlling processing-induced phase transitions.

Main Methods:

  • Nitrofurantoin anhydrate was granulated with four excipients of differing water-absorbing potentials using varying water content.
  • Wet masses were analyzed offline using X-ray powder diffractometry (XRPD) and near-infrared spectroscopy.

Related Experiment Videos

  • Drying phases were evaluated using variable temperature XRPD.

    • Main Results:

    • Amorphous excipients successfully retarded nitrofurantoin hydrate formation at high water content.
    • Hygroscopic, partially crystalline excipients hindered hydrate formation at low water content.
    • Crystalline excipients did not control API hydrate formation.

    Conclusions:

    • Excipient character significantly influences formulation stability by controlling API phase transitions.
    • Strategic selection of excipients is essential for managing processing-induced phase transformations and improving storage stability.